ID
44149
Description
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 16 Form
Keywords
Versions (2)
- 11/29/17 11/29/17 -
- 9/20/21 9/20/21 -
Copyright Holder
Gruppo Italiano Malattie EMatologiche dell'Adulto
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Visit 16 GIMEMA CML0408 NCT00769327
Visit 16
- StudyEvent: ODM
Description
Complete Blood Count
Alias
- UMLS CUI-1
- C0009555
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Complete Blood Count Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0005771
- UMLS CUI [1,2]
- C0011008
Description
Hemoglobin
Data type
integer
Measurement units
- g/L
Alias
- UMLS CUI [1]
- C0019046
Description
Leukocytes
Data type
integer
Measurement units
- x103/mL
Alias
- UMLS CUI [1]
- C0023516
Description
Platelets
Data type
integer
Measurement units
- x109/L
Alias
- UMLS CUI [1]
- C0005821
Description
polymorphonuclear
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C1168338
Description
Lymphocytes
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0024264
Description
Monocytes
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0026473
Description
Eosinophils
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0014467
Description
basophils
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0004827
Description
metamyelocytes
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0229635
Description
myelocytes
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0369715
Description
promyelocytes
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0033416
Description
blasts
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0368761
Description
Answer hematology
Data type
text
Alias
- UMLS CUI [1]
- C0474523
Description
Biochemistry
Alias
- UMLS CUI-1
- C1655775
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Date biochemistry examination
Data type
date
Alias
- UMLS CUI [1,1]
- C2826641
- UMLS CUI [1,2]
- C0005477
Description
Creatinine
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0201976
Description
Glucose
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0202042
Description
LDH
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0202113
Description
GOT
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201899
Description
GPT
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201836
Description
y-GT
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0202035
Description
Alkaline phosphatase
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201850
Description
Total Bilirubin
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0201913
Description
Amylase
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201883
Description
Lipase
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0373670
Description
calcium
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0201925
Description
Phosphorus
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0523826
Description
Potassium
Data type
integer
Measurement units
- mEq/L
Alias
- UMLS CUI [1]
- C0202194
Description
Magnesium
Data type
integer
Measurement units
- mEq/L
Alias
- UMLS CUI [1]
- C0373675
Description
Electrocardiogram
Alias
- UMLS CUI-1
- C1623258
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Date electrocardiogram
Data type
date
Alias
- UMLS CUI [1]
- C2826846
Description
Electrocardiographic anomalies
Data type
boolean
Alias
- UMLS CUI [1]
- C0522055
Description
Main electrocardiographic anomaly
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C1542147
Description
Echocardiogram
Alias
- UMLS CUI-1
- C2243117
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Date echocardiogram
Data type
date
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0011008
Description
Echocardiographic abnormalities
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C1704258
Description
Main echocardiographic anomaly
Data type
text
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C1542147
Description
Biopsie
Alias
- UMLS CUI-1
- C0005558
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Bone biopsy performed
Data type
boolean
Alias
- UMLS CUI [1]
- C0005954
Description
Date of bone marrow biopsy
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005954
Description
Reason biopsy not done
Data type
text
Alias
- UMLS CUI [1,1]
- C0332307
- UMLS CUI [1,2]
- C0005558
- UMLS CUI [1,3]
- C1272696
- UMLS CUI [1,4]
- C0678257
Description
Preservation of cellular samples
Alias
- UMLS CUI-1
- C0005822
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Stored cell sample
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1698986
Description
If not, indicate reasons
Data type
text
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1698986
- UMLS CUI [1,3]
- C2919806
Description
Date taken
Data type
date
Alias
- UMLS CUI [1,1]
- C0680532
- UMLS CUI [1,2]
- C0011008
Description
Laboratory
Data type
text
Alias
- UMLS CUI [1]
- C0681902
Description
Sample identifier
Data type
integer
Alias
- UMLS CUI [1]
- C4071975
Description
Cytogenetics
Alias
- UMLS CUI-1
- C0010802
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Cytogenetics performed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0010802
- UMLS CUI [1,2]
- C0884358
Description
Reason cytogenetics not performed
Data type
text
Alias
- UMLS CUI [1,1]
- C0445106
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0010802
Description
Date taken
Data type
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0010802
Description
Laboratory
Data type
text
Alias
- UMLS CUI [1]
- C0022877
Description
Number of metaphases examined
Data type
integer
Alias
- UMLS CUI [1,1]
- C1621812
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0260877
Description
Ph Phase metaphase number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0457343
Description
Percent metaphase Ph-
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0936012
- UMLS CUI [1,2]
- C0025564
- UMLS CUI [1,3]
- C0439165
Description
Additional abnormalities
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010802
Description
Number of metaphases with additional anomalies
Data type
integer
Alias
- UMLS CUI [1,1]
- C1621812
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1704258
Description
Description of Abnormalities
Data type
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1704258
Description
FISH (from bone marrow blood)
Alias
- UMLS CUI-1
- C0005953
- UMLS CUI-2
- C0162789
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
FISH performed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0884358
Description
Reason FISH not performed
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0162789
Description
Date FISH
Data type
date
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0011008
Description
Laboratory
Data type
text
Alias
- UMLS CUI [1]
- C0022877
Description
Sample
Data type
integer
Alias
- UMLS CUI [1]
- C0005834
Description
Number of cells analyzed
Data type
integer
Alias
- UMLS CUI [1]
- C2963401
Description
Number of bcr / abl + cells
Data type
integer
Alias
- UMLS CUI [1]
- C1835417
Description
Probe used
Data type
text
Alias
- UMLS CUI [1]
- C0016321
Description
Classic rearrangement
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2366845
- UMLS CUI [1,2]
- C3250978
Description
der (9) deletions
Data type
boolean
Alias
- UMLS CUI [1]
- C0495650
Description
Amplification bcr / abl
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3888919
- UMLS CUI [1,2]
- C0243148
Description
Variation shift
Data type
boolean
Alias
- UMLS CUI [1]
- C0205419
Description
Other
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1704258
Description
Result description
Data type
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0162789
Description
Molecular Biology (peripheral blood)
Alias
- UMLS CUI-1
- C0026376
- UMLS CUI-2
- C0229664
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Test performed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0884358
Description
Reason test not performed
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
Description
Date taken
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Laboratory
Data type
text
Alias
- UMLS CUI [1]
- C0022877
Description
RT-PCR Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0599161
- UMLS CUI [1,2]
- C2346633
Description
CT BCR/ABL
Data type
integer
Alias
- UMLS CUI [1]
- C1835417
Description
CT ABL
Data type
integer
Alias
- UMLS CUI [1]
- C1835417
Description
Ratio BCR/ABLx100/ABL
Data type
integer
Alias
- UMLS CUI [1,1]
- C0456603
- UMLS CUI [1,2]
- C2733507
- UMLS CUI [1,3]
- C0439165
Description
Nested PCR performed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0242574
- UMLS CUI [1,2]
- C0599161
Description
If yes, write down results
Data type
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0242574
- UMLS CUI [1,3]
- C0599161
Description
FISH (peripheral blood)
Alias
- UMLS CUI-1
- C0229664
- UMLS CUI-2
- C0162789
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
FISH performed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0884358
Description
Reason not performed
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0162789
Description
Date FISH
Data type
date
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0011008
Description
Laboratory
Data type
text
Alias
- UMLS CUI [1]
- C0022877
Description
Sample
Data type
integer
Alias
- UMLS CUI [1]
- C0005834
Description
Number of cells analyzed
Data type
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0936012
- UMLS CUI [1,3]
- C1274040
- UMLS CUI [1,4]
- C0007634
- UMLS CUI [1,5]
- C0439810
- UMLS CUI [1,6]
- C0750480
Description
Number of bcr / abl + cells
Data type
integer
Alias
- UMLS CUI [1,1]
- C1835417
- UMLS CUI [1,2]
- C0007584
- UMLS CUI [1,3]
- C0237753
Description
Probe used
Data type
text
Alias
- UMLS CUI [1,1]
- C0182400
- UMLS CUI [1,2]
- C4071975
Description
Classic rearrangement
Data type
text
Alias
- UMLS CUI [1,1]
- C2366845
- UMLS CUI [1,2]
- C3250978
Description
der (9) deletions
Data type
boolean
Alias
- UMLS CUI [1]
- C0495650
Description
Amplification bcr / abl
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3888919
- UMLS CUI [1,2]
- C0243148
Description
Variation shift
Data type
boolean
Alias
- UMLS CUI [1]
- C0205419
Description
Other
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1704258
Description
Result description
Data type
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0162789
Similar models
Visit 16
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
C0005954 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,4])
C1698986 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,2])
C2919806 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0010802 (UMLS CUI [1,3])
C0010802 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0260877 (UMLS CUI [1,3])
C0457343 (UMLS CUI [1,2])
C0025564 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0010802 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0162789 (UMLS CUI-2)
C0884358 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C3250978 (UMLS CUI [1,2])
C0243148 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,2])
C0229664 (UMLS CUI-2)
C0884358 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
C2346633 (UMLS CUI [1,2])
C2733507 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0599161 (UMLS CUI [1,2])
C0242574 (UMLS CUI [1,2])
C0599161 (UMLS CUI [1,3])
C0162789 (UMLS CUI-2)
C0884358 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0936012 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0007634 (UMLS CUI [1,4])
C0439810 (UMLS CUI [1,5])
C0750480 (UMLS CUI [1,6])
C0007584 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C4071975 (UMLS CUI [1,2])
C3250978 (UMLS CUI [1,2])
C0243148 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,2])